BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 2941106 · Received January 16, 2013

    Report

    Report Number
    2242352-2013-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, USING THE VASOVIEW 7XB, THE DISSECTION TIP WAS THREADED INCORRECTLY AND PLASTIC DEBRIS CAUSED AN OBSTRUCTED VIEW. THE DISSECTION TIP WAS REPLACED; HOWEVER, THE ISSUE REMAINED. DURING HARVESTING, THE C-RING SLIDER BECAME LOCKED INTO PLACE AND WAS UNABLE TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23920 VASOVIEW 7 XB ENDOSCOPIC VESSESL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25064989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA